The effects of Portulaca Oleracea extract on thirsty and 24 hour urine indices in patients with renal stone: a double-blind randomized placebo-controlled clinical trial
Patients are randomly allocated into two experimental groups. In the group 1, the patients received Portulaca Oleracea powder and standard treatment of stone based on urine metabolic evaluation (8 weeks) .
The group 2 receive Placebo (admixing 2 g of starch powder and 0.5 g brown sugar) and standard treatment of stone based on urine metabolic evaluation for 8 weeks . 24 h urine collection and Blood samples are drawn in 2steps. Study will be executed at Tehran Shahid modarres hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age 18-65 years and Literate , history of renal stone
Non-inclusion criteria: Patients with diabetes , Oral problems ,No use of angiotensin II inhibitors and Patients with colds
Intervention groups
The intervention group (n = 30) received Portulaca Oleracea extract and standard treatment of stone based on urine metabolic evaluation for 8 weeks . .The control group (n = 30) received theplacebo and standard treatment of stone based on urine metabolic evaluation for 8 weeks .
Main outcome variables
Serum sodium level, Serum potassium level, Total antioxidant; Blood creatinine, Blood urea, Serum uric acid, 24-hour uric acid; 24-hour urine citrate; , The degree of thirst.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170725035305N4
Registration date:2020-05-02, 1399/02/13
Registration timing:prospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Amirhesam Alirezaei
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3095
Email address
aalirezaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Portulaca Oleracea extract on thirsty and 24 hour urine indices in patients with renal stone: a double-blind randomized placebo-controlled clinical trial
Public title
The effects of Portulaca Oleracea extract on thirsty and 24 hour urine indices
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years
Literate
Exclusion criteria:
Patients with diabetes
Oral problems
No use of angiotensin II inhibitors
Patients with colds
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of balanced block randomization used with a block size of 4. For the allocation sequence, we applied computer-generated by random numbers. Medicines containing Oleracea extract or placebos with the same shape and color numbered with a code in sealed envelopes. Each coded prepared medication with a label by one number from 1 to 60. The patients allocated into two groups: group 1(n=30) received Oleracea extract, and group2 (n=30 ) received placebo . Both groups were identical in terms of characteristics and comorbid conditions; the participants divided sequentially.The control group is assigned to "A" and the intervention group to "B", and then the two groups are divided into 6 blocks: (1) AAB, (2) B A A, (3 (B), b), b), b), b), b), b) These blocks are randomly put together by computer and provide a chain of randomized groups (eg: B A B B A B B A B B A B B). Then the patients enter these groups in order of entry.
Blinding (investigator's opinion)
Double blinded
Blinding description
During study period ,a nurse coordinated the study and registered the study codes and the nurse handed the labeled drugs over participants and collected all the data. The patients , investigators , laboratory staffs and supervisers all were blinded to treatment assignment and lab data measurements during the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, chamran highway,Tehran, Iran.
City
tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-09-16, 1398/06/25
Ethics committee reference number
IR.SBMU.MSP.REC.1398.538
Health conditions studied
1
Description of health condition studied
Patients with kidney stones
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
serum Potassium level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
2
Description
serum Sodium level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
3
Description
24-hour urine uric acid
Timepoint
At the start of the study and at the end of the study
Method of measurement
24 h Urine collection
4
Description
24-hour urine citrate
Timepoint
At the start of the study and at the end of the study
Method of measurement
24 h Urine collection
5
Description
Specific weight of urine
Timepoint
At the start of the study and at the end of the study
Method of measurement
Urine sample
6
Description
24 hour urine calcium
Timepoint
At the start of the study and at the end of the study
Method of measurement
24 h Urine collection
7
Description
24-hour urine creatinine
Timepoint
At the start of the study and at the end of the study
Method of measurement
24 h Urine collection
8
Description
24-hour urine Na
Timepoint
At the start of the study and at the end of the study
Method of measurement
24 h Urine collection
Secondary outcomes
1
Description
Thirst intensity
Timepoint
At the start of the study, at the end of the study
Method of measurement
using Visual Analogue Scale
2
Description
serum triglycerid level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
3
Description
serum cholestrol level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
4
Description
serum HDL level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
5
Description
Total antioxidant level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
6
Description
ESR
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
7
Description
CRP
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
8
Description
serum Uric acid level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
9
Description
serum Creatinine level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
10
Description
serum Urea level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
11
Description
serum calcium level
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
12
Description
venous blood gas
Timepoint
At the start of the study and at the end of the study
Method of measurement
blood sample
Intervention groups
1
Description
Intervention group: The intervention group (n = 30) received a capsul containing of 2 grams Portulaca Oleracea hydro alcoholic extract and half a gram of brown sugar should be taken with 100 cc of water and standard treatment based on urine metabolic evaluation for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: The second group (30 patients) received placebo as a capsul containing of 2 grams starch powder and half a gram of brown sugar ( placebo ) should be taken with 100 cc of water and standard treatment based on urine metabolic evaluation for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modaress hospital of Tehran
Full name of responsible person
Amirhesam Alirezaei
Street address
Shahid Modaress hospital , Kaaj square , Saadat Abad , Tehran